Sr. Principal - Industrial Hygienist

Lilly

44d • Onsite

About The Position

Lilly is constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. The Industrial Hygienist is part of the Lilly Richmond Active Pharmaceutical Ingredient (API) Manufacturing Health, Safety, and Environmental (HSE) team and provides technical expertise and support in the development, implementation, and maintenance of HSE industrial hygiene (IH) programs and other HSE programs, as needed. This position will serve as the primary IH contact for a variety of areas (e.g., such as monoclonal antibodies and antibody drug conjugates manufacturing, laboratories, utilities, warehouse, etc.). In the project delivery and startup phases, the industrial hygienist role will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows through startup to full scale GMP manufacturing. Post start-up, this role will continue to be the subject matter expert and daily support for IH programs and other assigned HSE programs (as needed) within their assigned work areas.

Requirements

• Bachelor’s degree in Industrial Hygiene or related field
• 3+ years of Industrial Hygiene experience within cGMP manufacturing (pharmaceutical or chemical manufacturing preferred)
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Nice To Haves

• Experience in antibody drug conjugate manufacturing (drug substance and drug product).
• Demonstrated skills in technical expertise and self-motivation.
• Attention to detail and ability to be flexible depending on operational needs.
• Effective communication skills (oral, written, presentation, and negotiation) appropriate for all levels in the organization and a willingness to share information.
• A self-motivated, action-oriented, high-energy team player with demonstrated ability to work effectively in a highly collaborative organizational culture.
• Practices and earns trust and mutual respect.
• High degree of business and personal ethics and integrity.
• Analysis/problem assessment skills, communication (oral and written) skills, information monitoring skills, quality orientation, and teamwork/interpersonal skills.

Responsibilities

• Participate in project design meetings, support risk assessment and industrial hygiene/exposure control decisions.
• Responsible for developing and implementing written programs and applicable trainings.
• Develop and support the industrial hygiene implementation strategy working directly with the areas for implementation, troubleshooting, and auditing compliance.
• Participate in the development of the HSE operational readiness plan for the Lilly Richmond API facility as a collaborative, inclusive, and energetic member of the HSE team.
• Be a technical resource for assigned programs (e.g., hazard communication, exposure assessment, biological safety, personal protective equipment, etc.).
• Conduct workplace assessments to identify chemical, physical, and biological hazards, and develop IH prioritized monitoring plans (e.g. chemical, noise monitoring, ergonomics, and other assessments). Conduct the analysis of exposure assessment results and prepare reports on findings.
• Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, assure safety and compliance of new systems, and assist in setting requirements to assure safe and compliant startup.
• Be a resource to the operational areas in helping them understand the regulatory requirements of their areas and programs; work with them in implementing solutions that comply with these regulations and programs.
• Complete internal HSE audits/assessments, lead/support incident investigations, assist with trending HSE data and metrics compilation, and support the development of long-term plans to drive program improvements.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal